Device Dossier

PTFE Polymer Oval Pledgets - Cardiovascular patch, synthetic

Device Dossier for PTFE Polymer Oval Pledgets - Cardiovascular patch, synthetic (Cardiovascular patch, synthetic, Class III, sponsor Medtronic). ARTG…

Intended purpose

PTFE Polymer Oval Pledgets are indicated for use as non-absorbable suture buttresses when there is a possibility of suture tearing through tissue. These pledgets are used in various surgical procedures such as vascular closure, septal repair, myocardial closure, valvular suturing and hepatic repair.

Functional description

PTFE Polymer Oval Pledgets are nonabsorbable, undyed fabrics composed of poly (tetrafluoroethylene). PTFE Pledgets elicit a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the fabric by fibrous connective tissue. PTFE Pledgets are not absorbed, nor is any significant change in tensile strength retention known to occur in vivo.

TGA Public Summary